Dr. Jun Ishigooka, a prominent professor in psychopharmacology attached to Tokyo’s Women’s Medical University School of Medicine has given a great insight into the current trends in drug development for depression and has feedback has added value to this blog post.

Depression can affect anyone and it is becoming increasingly common in today’s fast moving materialistic world. Due to its decreased social functioning and increased mortality directly affecting, daily lives of individuals, many therapeutic agents have been developed to fight depression based on the monoamine hypothesis. In addition to drug therapy, ETC has been also approved for insurance, but it is not popular because the price and insurance points do not match.

Ketamine which is currently used as a dissociative anaesthetic, is also used in clinical trials for depression. However this narcotic drug, has concerns with its high level of side effects. In addition, there could be significant variations in symptomatic improvement compared to the placebo. It still remains unclear if patients will be able to improve their depression symptoms with ketamine, and fit enough to return to the society. When treating depression, clinicians try to, not only improve the symptoms but also the cognitive functions of the patients so that they can lead a normal life as before.

Improving cognitive function is an important therapeutic endpoint in the treatment of depression: When treating depression, clinicians try to, not only improve the symptoms but also the cognitive functions of the patients so that they can lead a normal life as before. However, it is questionable, if this can be judged to reveal a real clinical effect to demonstrate as an end point. Ketamine is not a drug which can be used permanently. In the USA and UK, esketamine is used as an antidepressant, but suggestions are present that its optical isomer alketamine performs better and needs attention for future research.

Controlling or reducing the placebo effect will lead to successful clinical trials: It has been observed that during the last two decades, the placebo effect is on the rise and many clinical trials were stopped not due to side effects of drugs but, because it  did not show any significant clinical results to prove efficiency. If clinical trials are done on a small scale, they can easily fail, however, investments for development of new drugs too remain low. Currently, there is no effective method as to how to bring about a reduction in the placebo effect. 

Reducing evaluation variability by introducing telemedicine technology: Japan, doesn’t have a specialised facility and therefore clinical trials are conducted in the clinical practice setting with low facilities. Also, due to the high number of clinical trial investigators involved, evaluation too can vary from one clinician to another. Thus, a pilot study was performed in January, at a central facility, using telemedicine technology. This has allowed patients to be evaluated at a central institution using the same rating scale. In addition, since it has reduced the number of evaluators, there is reduced variance. A clinical psychologist was assigned as a trainee to verify the effectiveness, but even if it works smoothly, it will take a few years for its implementation. This is an academic trial funded by several manufacturers.

Using wearable devices for clinical trials in depression studies: It is still early to say if data from wearable devices is a suitable option or not, to judge end-point evaluation in clinical trials done on depression. The wearable devices are only a good sign for viewing vital signs and activity and thus not effective in judging depression symptoms. Self-reports obtained with devices for depression can be helpful, but there is a gap with the time taken for investigator evaluation. Thus, in the case of depression patients, it might not be as effective as it is thought to be. 

The future of digital tools in the use of depression comes to treating patients with depression, there are long consultation hours at the time of diagnosis. Perhaps, in the future digital tools like “THINC-it” can be useful for screening cognitive impairment at the initial stages.

Points of success in clinical trials for depression: The recent antidepressant therapies particularly do not have very strong side effects, thus, the dropout rate from clinical trials is low compared to the past. The data collected from patients is sent to a third party for checking, and feedback is given telephonically to the clinical trial sites which help to improve the quality and the final result. This way, there is more transparency and an improvement is observed in clinical trial conduct.

To explore the opportunity please contact at imran@3h-ms.co.jp